Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Diclofenac sodium gel 1%
Diclofenac 1% · 1 trial · 1 indication
Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the clinical equivalence of Test Drug (Diclofenac sodium gel of 1% of Mylan Inc.) with the Reference Listed Drug (RLD) (Voltaren® Gel 1% of Novartis Consumer Health, Inc.) Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\]. The timepoints considered for the primary outcomes include baseline and week 4.
Mean change in the total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale score for the target knee was compared to determine the superiority of the Test Drug and Reference Listed Drug (RLD) over placebo. Measure Description: Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale score (pain score = min 0 to max 20), was determined by the sum of subject's responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4). Higher values represent worse outcome. 'How much pain do you have' when 'Walking on a flat surface' (S1), 'Going up or down stairs' (S2), 'at night while in bed' (S3), 'Sitting or lying' (S4), 'Standing upright' (S5)\]. The timepoints considered for the primary outcomes include baseline and week 4.
| Arm | Type | Description |
|---|---|---|
| Diclofenac Sodium Gel | EXPERIMENTAL | Diclofenac Sodium Gel, 1% |
| Voltaren® Gel | ACTIVE_COMPARATOR | Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% |
| Placebo gel | PLACEBO_COMPARATOR | Placebo gel |
| Name | Type | Description |
|---|---|---|
| Diclofenac sodium gel 1% | DRUG | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% | DRUG | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Placebo gel | DRUG | Vehicle Gel 4 gm, 4 times a day for 4 weeks |
Inclusion Criteria: * Osteoarthritis knee as per American College of Rheumatology (ACR) criteria * Evidence of OA with Kellgren-Lawrence grade 1-3 disease. * After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee * After discontinuing all pain medicat...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
Diclofenac 1% is a topical gel used for the treatment of osteoarthritis of the knee. It is applied to the skin over the affected joint to provide localized relief. The drug is being developed by Viatris Inc. and has been studied in a Phase 3 clinical trial in patients with knee osteoarthritis.
Diclofenac 1% works by inhibiting the enzymes PTGS2 (cyclooxygenase-2) and PTGS1 (cyclooxygenase-1). These enzymes are involved in the production of prostaglandins, which mediate pain and inflammation. By inhibiting these targets, the drug reduces pain and swelling in the treated area. It is a small molecule inhibitor.
Diclofenac 1% is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is a global pharmaceutical company that focuses on providing access to medicines. The company is responsible for the development and potential commercialization of this topical gel formulation.
Diclofenac 1% is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug is not yet approved. It remains an investigational product for the treatment of knee osteoarthritis. Further regulatory steps would be required before it could become available to patients.
Diclofenac 1% has been studied in a completed Phase 3 clinical trial, NCT03172780, titled "A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee." This randomized, double-blind, placebo-controlled trial enrolled 1,220 participants with knee osteoarthritis in India.
Yes, Diclofenac 1% is also known as Diclofenac sodium gel 1%. These names refer to the same topical formulation developed by Viatris Inc. for knee osteoarthritis. The 1% strength indicates the concentration of diclofenac sodium in the gel.